Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial

Loke, Paxton; Orsini, Francesca; Lozinsky, Adriana Chebar; Gold, Michael; O’Sullivan, Michael; Quinn, Patrick; Lloyd, Melanie; Ashley, Sarah; Pitkin, Sigrid; Axelrad, Christine; Metcalfe, Jessica; Su, Ee Lyn; Tey, Dean; Robinson, Marnie; Allen, Katrina J.; Prescott, Susan L.; Galvin, Audrey Dunn; Tang, Mimi L.K.

doi:10.1016/s2352-4642(22)00006-2

Cited by 76 publications

(95 citation statements)

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“…Children in remission had significantly greater improvement in HRQL compared with children who were only desensitized (without remission), suggesting that remission is a better outcome for patients ( 28 ). Children in remission were also shown to have significantly greater improvement in HRQL compared to children who remained allergic and continued with allergen avoidance ( 28 ). Based on these findings, the lack of conclusive evidence that OIT improves HRQL in other studies may relate to patients only achieving desensitization, rather than remission ( 26 , 33 ).…”

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

“…There is limited data evaluating the impact of different clinical health states (allergic, desensitized without remission, and remission) on HRQL and other important patient-centered outcomes. Several studies suggest an interaction between allergy status and HRQL ( 25 , 27 , 28 ). The PPOIT-003 study included a 12-month follow-up period which provided a vital snapshot of the real-world post-treatment scenarios for children who achieved remission, desensitization alone (without remission) or remained allergic, allowing direct assessment of these interactions ( 28 ).…”

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

“…Several studies suggest an interaction between allergy status and HRQL ( 25 , 27 , 28 ). The PPOIT-003 study included a 12-month follow-up period which provided a vital snapshot of the real-world post-treatment scenarios for children who achieved remission, desensitization alone (without remission) or remained allergic, allowing direct assessment of these interactions ( 28 ). Children with remission were eating peanut as desired, while desensitized children were taking a daily treatment dose of peanut while avoiding all other peanut, and allergic children were avoiding all peanut.…”

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

“…Children with remission were eating peanut as desired, while desensitized children were taking a daily treatment dose of peanut while avoiding all other peanut, and allergic children were avoiding all peanut. The vast majority of children with remission were having regular exposure to substantial amounts of peanut, with 94% eating peanut at least monthly, and 80% eating 600 mg peanut protein or more at a single ingestion ( 28 ). Children in remission had significantly greater improvement in HRQL compared with children who were only desensitized (without remission), suggesting that remission is a better outcome for patients ( 28 ).…”

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

“…The vast majority of children with remission were having regular exposure to substantial amounts of peanut, with 94% eating peanut at least monthly, and 80% eating 600 mg peanut protein or more at a single ingestion ( 28 ). Children in remission had significantly greater improvement in HRQL compared with children who were only desensitized (without remission), suggesting that remission is a better outcome for patients ( 28 ). Children in remission were also shown to have significantly greater improvement in HRQL compared to children who remained allergic and continued with allergen avoidance ( 28 ).…”

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

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Measuring the Impact of Food Immunotherapy on Health-Related Quality of Life in Clinical Trials

2022

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Food allergy is a common, and often lifelong, disorder with considerable negative impact on the quality of life of those affected and their families. While several promising immunotherapies for food allergy have either been approved or are in late-phase clinical trials based on demonstrated effectiveness at inducing desensitization, evidence of benefit in terms of improving patient-centered outcomes is inconsistent. Historically, health-related quality of life has not been prioritized as an endpoint in food immunotherapy trials and, even when included, findings have been undermined by methodological limitations of the measurement instruments used and issues with data interpretation. This review highlights the importance of measuring health-related quality of life as an endpoint in food immunotherapy trials and discusses the strengths and limitations of available evidence in this regard, with a focus on the appropriate use of assessment instruments and interpretation of findings. There remains much to learn regarding the impact of food immunotherapies on patient wellbeing, both during treatment and over the longer term. Our aim is to assist clinicians, researchers, policy makers and consumers in their interpretation of the existing literature, and to promote greater scientific rigor in the design and selection of outcome measurement frameworks for future studies evaluating the efficacy of immunotherapy treatments for food allergy.

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Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

Section: Considerations When Interpreting Hrql Measurementsmentioning

confidence: 99%

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Measuring the Impact of Food Immunotherapy on Health-Related Quality of Life in Clinical Trials

2022

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Efficacy and safety of oral immunotherapy for peanut, cow's milk, and hen's egg allergy: A systematic review of randomized controlled trials

Lodge

Waidyatillake

Peters

et al. 2023

Clinical & Translational All

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Background Oral immunotherapy (OIT) is a promising treatment for food allergies; however, safety is a concern. We synthesized evidence from the best randomized controlled trials (RCTs) on efficacy/safety of OIT for desensitization (DS) and remission (sustained unresponsiveness (SU)) in IgE mediated allergy to peanut, hen's eggs, and cow's milk. Body We searched Pubmed, EMBASE, and Cochrane databases (Until Oct 22) identifying 16 eligible RCTs published in English measuring food allergy by food challenge at the beginning and at the end of the study. The Cochrane Risk of Bias tool was used to assess study quality. We found 18 eligible studies. There was evidence of efficacy for DS for all allergens: peanut (RR 11.32; 95% CI 5.93, 21.60, I2 49%, 8 studies); hen's egg (RR 4.67; 2.66, 8.21, I2 0%, 5 studies); cow's milk (RR 13.98; 3.51, 55.65, I2 0%, 4 studies) and evidence for SU for peanut (RR 7.74; 2.90, 20.69, I2 0%, 3 studies) and hen's egg (RR 6.91; 1.67, 28.57, I2 0%, 2 studies). Allergic events were increased with intervention, and risk of adrenaline use increased for peanut RR 2.96; 1.63, 5.35, I2 0%, 8 studies; egg RR 1.71; 0.42, 6.92, I2 0%, 6 studies; and milk RR 8.45; 2.02, 35.27, I2 0%, 4 studies. Conclusion We found strong evidence that peanut, hen's egg, and cow's milk OIT can induce DS and some evidence for remission. There was a high risk of allergic reactions. Generalizability to the entire food allergic population is not known.

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Targeting Food Allergy with Probiotics

Carucci,

Coppola,

Carandente

et al. 2024

Advances in Experimental Medicine and Biology

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Probiotic peanut oral immunotherapy versus oral immunotherapy and placebo in children with peanut allergy in Australia (PPOIT-003): a multicentre, randomised, phase 2b trial

Cited by 76 publications

References 41 publications

Measuring the Impact of Food Immunotherapy on Health-Related Quality of Life in Clinical Trials

Measuring the Impact of Food Immunotherapy on Health-Related Quality of Life in Clinical Trials

Efficacy and safety of oral immunotherapy for peanut, cow's milk, and hen's egg allergy: A systematic review of randomized controlled trials

Targeting Food Allergy with Probiotics

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